DAYTIME MUCUS RELIEF SEVERE CONGESTION AND COUGH AND NIGHTTIME COLD AND FLU MAXIMUM STRENGTH- dextromethorphan hbr, guaifenesin, phenylephrine hcl, acetaminophen, diphenhydramine hcl, phenylephrine hcl 
CVS Pharmacy

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active ingredients for Day Time (in each 20 mL)

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Phenylephrine HCl 10 mg

Active ingredients for Night Time (in each 20 mL)

Acetaminophen 650 mg

Diphenhydramine HCl 25 mg

Phenylephrine HCl 10 mg

Purposes for Day Time

Cough suppressant

Expectorant

Nasal decongestant

Purpose for Night Time

Pain reliever/fever reducer

Antihistamine/Cough suppressant

Nasal decongestant

Uses

Daytime

Nighttime

Warnings

 Nighttime

Liver warning :

This product contains acetaminophen. Severe liver damage may occur if you take

Allergy alert:

Acetaminophen may cause severe skin reactions. Symptoms may include:

If a skin reaction occurs, stop use and seek medical help right away

Sore throat warning:

If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do not use

Daytime

  • if you are taking a prescription monoamine oxidase inhibitor (MAOI) (certan drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
  • for children under 12 years of age

Nighttime

  • With any other drug containing acetaminophen (prescription or nonprescription ). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • with any other drug containing diphenhydramine, even one used on the skin
  • if you are taking a prescription monoamine oxidase inhibitor (MAOI) (certan drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product
  • for children under 12 years of age

Ask a doctor before use if you have

Daytime

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, emphysema
  • cough that occurs with too much phlegm (mucus)

Nighttime

  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • cough that occurs with too much phlegm (mucus)

Ask a doctor or pharmacist before use if

Nighttime

  • you are taking the blood thinning drug warfain
  • you are taking sedatives or tranquilizers

When using this product

Daytime

do not use more than directed.

Nighttime

  • do not use more than directed
  • excitability may occur, especially in children
  • marked drowsinessmay occur
  • alcohol, sedative, and tranquilizers may increase drowsiness
  • avoid alcohol drinks
  • be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

Daytime

  • nervousness, dizziness or sleeplessness occur
  • symptoms do not get better within 7 days or occur with fever
  • cough comes back, or occurs with fever, rash, or headache that lasts.

These could be signs of a serious condition.

Nighttime

  • nervousness, dizziness, or sleeplessness occur
  • pain, nasal congestion, or cough gets worse, or lasts more than 7 days
  • fever gets worse, or last more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • cough comes back, or occurs with fever, rash, or headache that lasts.

These could be signs of a serious condition.

If pregnant or breast-feeding,

Daytime

 ask a health professional before use

Nighttime

ask a health professional before use

Keep out of reach of children.

Daytime

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Nighttime

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adult as well as for children even if you do not notice any signs or symptoms

Directions

Daytime


Nighttime


Other information

Daytime

Nighttime

Inactive ingredients

Inactive ingredients for Day Time 

 citric acid, disodium EDTA, FD&C blue #1 FD&C red #40, flavor, glycerin, propyl gallate,  propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose,xanthan gum

Inactive ingredients for Night Time 

 citric acid, EDTA disodium, FD&C blue #1, Fd&C red #40, flavor, glycerin, propylene gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum

Principal Display Panel

DAYTIME

Severe Cough & Congestion

DEXTROMETHORPHAN HBr - Cough Suppressant

GUAIFENESIN -  Expectorant

PHENYLEPHRINE HCI - Nasal Decongestant

MAXIMUM STRENGTH

Multi-Symptom

For ages 12 & over

FL OZ (mL)

Compare to the active ingredients in Maximum Strength Mucinex®FAST-MAX® Severe Congestion & Cough and Nighttime Cold & Flu*

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND OR UNDER CAP IS BROKEN OR MISSING

*This product is not manufactured or distributed by Reckitt Benckiser, distributor of Maximum Strength Mucinex® FAST-MAX® Severe Congestion & Cough & Nighttime Cold & Flu

NIGHTTIME

Cold & FLU

ACETAMINOPHEN - Pain Reliever ; Fever Reducer

DIPHENHYDRAMINE HCl -  Antihistamine / Cough Suppressant

PHENYLEPHRINE HCl / Nasal Decongestant

MAXIMUM STRENGTH

Multi-Strength

For ages 12 & over

FL OZ (mL)

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

CVS.com

Product Label

Dextromethorphan HBr 20 mg, Guaifenesin 400 mg, Phenylephrine HCI 10 mg, Acetaminophen 650 mg, Diphenhydramine HCI 25 mg, Phenylephrine 10 mg

CVS HEALTH Severe Cough & Congestion Nighttime Cold & Flu

DAYTIME MUCUS RELIEF SEVERE CONGESTION AND COUGH AND NIGHTTIME COLD AND FLU  MAXIMUM STRENGTH
dextromethorphan hbr, guaifenesin, phenylephrine hcl, acetaminophen, diphenhydramine hcl, phenylephrine hcl kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-462
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69842-462-121 in 1 KIT; Type 0: Not a Combination Product04/30/2018
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE, PLASTIC 177 mL
Part 21 BOTTLE, PLASTIC 177 mL
Part 1 of 2
DAYTIME MUCUS RELIEF SEVERE CONGESTION AND COUGH  MAXIMUM STRENGTH
dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid
Product Information
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 20 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg  in 20 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 20 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYL GALLATE (UNII: 8D4SNN7V92)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34104/30/2018
Part 2 of 2
NIGHTTIME COLD AND FLU  MAXIMUM STRENGTH
acetaminophen, diphenhydramine hcl, phenylephrine hcl liquid
Product Information
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg  in 20 mL
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg  in 20 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 20 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYL GALLATE (UNII: 8D4SNN7V92)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34104/30/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34104/30/2018
Labeler - CVS Pharmacy (062312574)

Revised: 10/2019
Document Id: bee9851d-56ae-480c-a1d9-c60a16721485
Set id: 91c803c8-6cf8-4ff6-b376-ea6d65f9f227
Version: 2
Effective Time: 20191031
 
CVS Pharmacy